A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-escalating Study to Assess Safety, Tolerability and Pharmacokinetics of 0.1% and 1.0% ZEP-3 Cream, Administered Topically in Healthy Volunteers.
Overview
- Phase
- Phase 1
- Intervention
- 0.1% ZEP-3 cream
- Conditions
- Healthy
- Sponsor
- Shulov Innovate for Science Ltd. 2012
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Topical skin safety evaluation
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
It is a phase I randomized, double blind, placebo-controlled, dose-escalating study to assess safety, tolerability and pharmacokinetics (PK) data of 0.1% and 1.0% ZEP-3 cream, administered topically up to 5 consecutive treatment days in healthy volunteers.
This is a single center trial. It is anticipated that the study will be conducted at the Department of Dermatology, at the Sheba Medical Center, Ramat Gan, Israel.
The screening/enrollment visit includes a PK study for 24h following a single IP topical application. After a 24h washout time break, the subject will enter the treatment period for 5 consecutive treatment days followed by a follow up visit 1 and 5 days after end of treatment.
Detailed Description
The primary endpoints of this study are: * Safety evaluation - To demonstrate ZEP-3 cream safety in terms of skin irritation score. * Safety evaluation - To demonstrate ZEP-3 cream safety in terms of type and severity of reported adverse events. * Tolerability evaluation - To demonstrate ZEP-3 cream tolerability in terms of treatment compliance by the treated volunteers. The secondary endpoints of this study are: * Systemic absorption PK profile. * Dermal absorption PK profile (Optional). Subject safety will be assessed following treatment by ZEP-3 cream, using measurements of the following variables: * Dermal reaction parameters * Physical examination * Vital Signs (HR, BP, RR, Body temperature) * 12 lead ECG data * Laboratory tests (CBC, blood chemistry, coagulation functions, urinalysis) * Adverse events recording * Change in concomitant medications
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject must voluntarily sign and date the written Informed Consent prior to any study specific procedures
- •Subject, either men or women is between 18 and 50 years of age.
- •Subject, Body mass index (BMI) is within the normal to overweight range (See appendix 2)
- •Subject must have healthy skin on which reddening can be easily recognized in the area where they will place the test article
- •Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
- •Subject is willing to participate in the study and adhere to the study protocol
- •Females of childbearing potential should either be surgically sterile, or should use a highly effective medically accepted contraceptive regimen.
Exclusion Criteria
- •Subject has hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields
- •Dark skinned persons whose skin color prevents ready assessment of skin reactions
- •Subject with history of skin disorders or any active skin condition involving the test fields including but not limited to bacterial, viral, or fungal skin infections, acne, rosacea
- •UV therapy or significant UV exposure in the four weeks before treatment application
- •Subject with renal failure (Cr \> 2 mg/dl) or Subject with impaired hepatic function (ALT, AST 2-fold higher than normal upper limit value).
- •Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease
- •Subject suffers from an autoimmune disease (Diabetes, Lupus. Chron ect.)
- •History of malignancy
- •Sever illness or surgery within the previous 3 months (except for minor cosmetic or dental procedures)
- •Treatment with any investigational agent in another clinical trial within 1 month prior to start of this study.
Arms & Interventions
0.1% ZEP-3 cream
250 mg of ZEP-3 Cream 0.1% is applied on the right ventral forearm and 250 mg placebo is applied on the left ventral forearm 4 times daily
Intervention: 0.1% ZEP-3 cream
placebo
250 mg of ZEP-3 Cream 1.0% is applied on the right ventral forearm and 250 mg placebo is applied on the left ventral forearm 4 times daily
Intervention: placebo
Outcomes
Primary Outcomes
Topical skin safety evaluation
Time Frame: Change in skin clinical presentation up to 5 consecutive treatment days
Skin irritation
Secondary Outcomes
- Systemic absorption(During 24 hours following initial application)